New preclinical findings show enhanced liver protection with DA-1241 and Efruxifermin combo in advanced MASH model
The clinical-stage biotech company developing treatments for cardiometabolic diseases MetaVia Inc. (Nasdaq: MTVA), has unveiled new preclinical data supporting a combination therapy approach for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease characterized by fat buildup in the liver accompanied by inflammation and cell damage. The findings, were presented on June 22 at the American Diabetes Association's 85th Scientific Sessions in Chicago, demonstrate that MetaVia's investigational drug DA-1241, when paired with fibroblast growth factor 21 (FGF21) analogue Efruxifermin, offers enhanced hepatoprotective benefits beyond what either therapy achieves alone.
DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist previously shown in MetaVia's Phase 2a trial to improve liver and glucose metabolism in presumed MASH patients. The new preclinical data builds on those results, revealing that the combination therapy with Efruxifermin significantly reduced liver fat, inflammation, and fibrosis in a biopsy-confirmed MASH mouse model.
This combination therapy demonstrated, for the first time, beneficial synergistic effects in reducing liver fat, inflammation, and fibrosis, all key drivers of MASH progression. This reinforces our belief in the therapeutic potential of DA-1241 as part of a combination strategy to address the complex pathology of MASH," said MetaVia President and CEO Hyung Heon Kim.
In the 12-week study, mice fed a Gubra Amylin NASH (GAN) diet for 36 weeks to develop advanced MASH were randomized to receive vehicle, DA-1241, Efruxifermin, or the combination. DA-1241 remained weight-neutral, while Efruxifermin alone caused a 17% weight reduction. However, no additional weight loss was observed with the combination, suggesting the added liver benefits were independent of body weight changes.
The combination therapy resulted in greater reductions in plasma transaminases, hepatic cholesterol, and histological markers than either drug alone. Specifically, 94% of mice receiving the combination achieved at least a two-point improvement in the NAFLD activity score, significantly outperforming both monotherapies.
About MetaVia
MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects.
For more information, please visit www.metaviatx.com.
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